
[Federal Register Volume 83, Number 239 (Thursday, December 13, 2018)]
[Notices]
[Pages 64132-64133]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-26957]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-3984]


Data Integrity and Compliance With Drug CGMP: Questions and 
Answers; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a final guidance for industry entitled ``Data 
Integrity and Compliance With Drug CGMP: Questions and Answers.'' The 
purpose of the guidance is to clarify the role of data integrity in 
current good manufacturing practice (CGMP) for drugs. (Unless otherwise 
noted, the term CGMP refers to CGMPs for drugs, including biologics.) 
The guidance has been developed in response to an increase in findings 
of data integrity lapses in recent inspections. FDA expects that all 
data be reliable and accurate. CGMP regulations and guidance allow for 
flexible and risk-based strategies to prevent and detect data integrity 
issues. Firms should implement meaningful and effective strategies to 
manage their data integrity risks based on their process understanding 
and knowledge management of technologies and business models.

DATES: The announcement of the guidance is published in the Federal 
Register on December 13, 2018.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2018-D-3984 for ``Data Integrity and Compliance With Drug CGMP: 
Questions and Answers.'' Received comments will be placed in the docket 
and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at https://www.regulations.gov or at the Dockets 
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of this guidance to the 
Division of Drug Information, Center for Drug Evaluation and Research, 
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale 
Building, 4th Floor, Silver Spring, MD 20993-0002; the Office of 
Communication, Outreach and Development, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002; or 
the Policy and Regulations Staff (HFV-6), Center for Veterinary 
Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville, 
MD 20855. Send one self-addressed adhesive label to assist that office 
in processing your requests. See the SUPPLEMENTARY INFORMATION section 
for electronic access to the guidance document.

[[Page 64133]]


FOR FURTHER INFORMATION CONTACT: Karen Takahashi, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave. Bldg. 75, Rm. 6686, Silver Spring, MD 20993-0002, 301-
796-3191; Stephen Ripley, Center for Biologics Evaluation and Research, 
Food and Drug Administration, 10903 New Hampshire Ave. Bldg. 71, Rm. 
7301, Silver Spring, MD 20993-0002, 240-402-7911; or Jonathan Bray, 
Center for Veterinary Medicine (HFV-232), Food and Drug Administration, 
7519 Standish Pl., Rm. 130, Rockville, MD 20855, 240-402-5623.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Data Integrity and Compliance With Drug CGMP: Questions and 
Answers.'' In recent years, FDA has increasingly observed CGMP 
violations involving data integrity during CGMP inspections. This is 
troubling because ensuring data integrity is an important component of 
industry's responsibility to ensure the safety, efficacy, and quality 
of drugs, and of FDA's ability to protect the public health. These data 
integrity-related CGMP violations have led to numerous regulatory 
actions, including warning letters, import alerts, and consent decrees. 
The underlying premise in 21 CFR 210.1 and 212.2 is that CGMP sets 
forth minimum requirements to assure that drugs meet the standards of 
the Federal Food, Drug, and Cosmetic Act regarding safety, identity, 
strength, quality, and purity.
    The guidance addresses specific questions about how data integrity 
relates to compliance with CGMP for drugs, as well as more general data 
integrity concepts, in question and answer format. This guidance was 
published as a draft guidance in April 2016--``Data Integrity and 
Compliance With CGMP''--and has been revised in response to comments 
from the docket for clarity. Other comments to the docket requested 
additional details on FDA's thinking on current best practices and 
additional examples. The Agency has used clarifying language and 
additional examples that also address best practices for ensuring data 
integrity. A paragraph regarding independent security role assignments 
for small operations or facilities was removed because the guidance for 
industry ``PET Drugs--Current Good Manufacturing Practice (CGMP)'' 
covering this topic is sufficiently clear.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on data integrity and compliance with drug 
CGMP. It does not establish any rights for any person and is not 
binding on FDA or the public. You can use an alternative approach if it 
satisfies the requirements of the applicable statutes and regulations. 
This guidance is not subject to Executive Order 12866.

II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information that are subject to review by the Office of Management and 
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information in 21 CFR parts 210 and 211 
(CGMPs), 212 (positron emission tomography CGMPs), and 11 (electronic 
records and signatures) have been approved under OMB control numbers 
0910-0139, 0910-0667, and 0910-0303, respectively.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm, or https://www.regulations.gov.

    Dated: December 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-26957 Filed 12-12-18; 8:45 am]
 BILLING CODE 4164-01-P


